~ Monday! $WHRT ~ Earnings posted, pending or coming soon! In Charts and Links Below!
~ $WHRT ~ Earnings expected on Monday *
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*If the earnings date is in error please ignore error. I do my best.
What a disappointment , I have held the stock for several years and now it seems that the wait will begin anew. I am glad the FDA saw fit to do what it did. I would not want to have gains over
someone's health. Nevertheless it shows that even the brightest in the Penny Stocks can turn
out to be not so bright after all.
Good luck to all, and GOD bless from a not very religious, but honest old man.
Thank you so much, I really appreciate the information.
Hi PsD, I copied this from the last 10Q released in May. Our time is drawing nearer each day, IMO.
Our business is focused on the development and sale of VADs, particularly our Levacor VAD (Levacor VAD or Levacor). VADs are mechanical assist devices that supplement the circulatory function of the heart by re-routing blood flow through a mechanical pump allowing for the restoration of normal blood circulation. The Levacor VAD uses a magnetically levitated rotor resulting in no moving parts subject to wear, which is expected to provide multi-year support. In August 2009, we received conditional approval of our Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) for the Levacor VAD to begin a BTT clinical study. In January 2010, we received unconditional IDE approval from the FDA. In February 2011, the Company decided to pause enrollment in the BTT study while three refinements are made to its Levacor VAD based on initial clinical experience until certain device refinements could be made and the FDA reviews and approves the refinements. These refinements are the projection of the inflow cannula into the ventricle, the elimination of a false alarm that has led to controller exchanges and the optimization of surface finishing/coating manufacturing processes. To date, we have completed refinements related to the projection of the inflow cannula and the elimination of the controller false alarm. We expect the design modification related to the optimization of the surface finishing/coating manufacturing process will be complete in the next two months. However, in light of ongoing communications with the FDA, the timeline for implementation of these refinements is dependent on review and approval by the FDA which is uncertain. We do not expect to receive FDA approval to restart our BTT study any earlier than the end of the third quarter 2011. Due to this uncertainty, it is anticipated that enrollment will not begin any earlier than the end of the third quarter 2011.
VADs are used for treatment of patients with severe heart failure, including patients whose hearts are irreversibly damaged and cannot be treated effectively by medical or surgical means other than transplant. BTT therapy involves implanting a VAD in a transplant eligible patient to maintain or improve the patient's health until a donor heart becomes
available. DT is the implanting of a VAD to provide long-term support for a patient not currently eligible for a natural heart transplant. Bridge-to-Recovery involves the use of VADs to restore a patient's cardiac function helping the natural heart to recover and thereby allowing removal of the VAD.
In addition, we, in conjunction with a consortium consisting of the University of Pittsburgh, Children's Hospital of Pittsburgh, Carnegie Mellon University and LaunchPoint Technologies, Inc. (LaunchPoint) have been developing a small, magnetically levitated, rotary pediatric VAD (PediaFlow VAD). The PediaFlow VAD is intended for use in newborns and infants and has been primarily funded by the National Institutes of Health (NIH). In February 2011, the FDA granted Humanitarian Use Device (HUD) designation for the PediaFlow VAD. The HUD designation is given to devices that are intended to benefit patients with conditions that affect fewer than 4,000 patients per year. Under the HUD designation, manufacturers are required to demonstrate safety and the probable benefit of their device.
The technology embodied in the PediaFlow VAD also forms the basis for our small, minimally invasive VAD. The minimally invasive VAD is aimed at providing partial to full circulatory support in both early-stage and late-stage heart failure patients. We expect to be in an adult clinical trial with the minimally invasive VAD in 2014, contingent on our ability to obtain future financing and our ability to satisfactorily complete all regulatory requirements. We are exploring various strategic options to accelerate our development of the minimally invasive VAD.
You are right. Thank You.
They are recorded as option awards.
INSIDERS ARE STILL BUYING as of 6/23/11
I was hoping for an update before the schedule meeting.
Buying by insiders is a good sign though.
It appears to be turning around. FDA delay is holding the price down.
Going down on very low volume. when buyers buy
the volume is high. Insiders are still buying. My advice
for whatever it's worth, don't sell, things should turn
around soon when the finishing touches are finished.
Annual meeting coming up on June 23. I am hoping
we have finished the refinements by then or a better
explanation of the delay.
Here's some info. on the private placement.
I just bought more, 1000 more today 3000 this week.
There is hardly any volume because large investors
own most of the stocks and they are not selling.
I've had shares for several years and like I
say to my relatives, the time to buy is now
it's not going to go much lower. In my opinion
it has hit it's low.
Thanks for the info man I have been watching this one for weeks now just trying to build my kitty so when the time is right I can load the boat and not be impatient.
Investors continue buying, as of 02/15/2011.
Patient enrollment should re-start soon as
regulatory requirements appears to be over
soon. Insiders and Large Investors now own
Could you please give me a quick rundown on this one looks like its getting about time for a big reversal imo.
The stock has been on a tear since the financing was announced...up almost 40%. fyi, the 20dma just crossed the 50dma...from a technical standpoint we don't hit resistance until 3.05.
Wedbush says Medicare decision positive for ventricular device makers
In a note to investors, Wedbush analysts Dr. Duane Nash and Akiva Felt wrote that weakness in providers of left ventricular assist devices - including Thoratec (THOR), HeartWare (HTWR), and WorldHeart (WHRT) - could create an attractive entry point for investors.
Wedbush notes that the CMS said last night it is not expanding left ventricular assist device, or LVAD, reimbursement to include to Class IIIB patients. However, the firm points out CMS did make positive changes to the objective criteria. Wedbush recommends using any weakness in shares of Thoratec (THOR), HeartWare (HTWR), and World Heart (WHTR) following the news as buying opportunities.
4th center has now implanted World Heart's LVAD.
SALT LAKE CITY, July 6, 2010 (GLOBE NEWSWIRE) -- World Heart Corporation (WorldHeart) (Nasdaq:WHRT - News), a developer of mechanical circulatory systems, announced today that Jewish Hospital in Louisville, Kentucky, successfully implanted a Levacor(TM) Ventricular Assist Device (VAD) in the Bridge-to-Transplant (BTT) clinical study. This is the eighth implant of the Levacor VAD in the fourth implanting center in the study.
Dr. Mark Slaughter, Chief of the Division of Thoracic and Cardiovascular Surgery, Jewish Hospital/University of Louisville, and surgical co-Principal Investigator of the study at Jewish Hospital indicated, "I am excited by our initiation of patient enrollment in this study. We are pleased to provide a fully magnetically levitated VAD therapy to our late-stage heart failure patients. This is part of our ongoing efforts to find ways to reduce complications and improve outcomes."
Mr. J. Alex Martin, WorldHeart's President and Chief Executive Officer noted, "We are pleased to continue to expand the BTT clinical study at Jewish Hospital led by Dr. Mark Slaughter, a top thought leader in mechanical circulatory support therapy. "
WHRT continues to execute on its plan.
The University of Utah Hospital and INTEGRIS Baptist Medical Center in Oklahoma City have successfully implanted additional Levacor(TM) Ventricular Assist Devices (VAD) in the Bridge-to-Transplant (BTT) clinical study. These are the sixth and seventh implants, respectively, with the Levacor VAD since the inception of the BTT clinical study.
Three New Clinical Sites
The addition of the University of Louisville/Jewish Hospital, Massachusetts General Hospital in Boston, and Tampa General Hospital puts the company right on track to meet it's stated goal of having 10 nationwide centers on line in the Levacor BTT Study by September.
Worldheart's slides from Canaccord Adams Cardiovascular Conference...good explanation of competitive products and Levacor's differentiation.
WHRT's market cap is roughly the same as it was when the current investors recapitalized the company approximately 2 years ago. Since then they've gotten the LVAD approved, started clinical trials, and begun generating revenue. Yet, you can buy in today at half of what insiders just paid in January.
When one considers that 100,000 patients need transplants each year but only 2,000 get them, I believe the market for LVAD's is going to grow significantly. Whether World Hearts device will be one of the winners remains to be seen but considering HTWR's market cap is over 800 million, I like the upside.
With the Levacor VAD Bridge-to-Transplant (BTT) clinical study underway, it's nice to see the company generating revenue. Based on the $556k booked in just the 1Q, it looks like their recovering around $185k per patient.
Currently the company has 3 medical centers participating but plans to bring on an additional 7 by the end of the summer which should result in more implants and greater revenue.
Careful now Don. FYI,I bought 500 shares of this company 15 years ago. Because of so called "smart" venture capitalists and all the reverse splits over the years the company has subjected its shareholders to, my 1500 dollars that I invested has been reduced to one share of stock.
It appears you've got some smart venture capitalists who've recently put in $$$ at over $5 a share.
26-Jan-10 NEW LEAF VENTURES II, L.P.
Beneficial Owner (10% or more) 388,350 Direct Purchase at $5.15 per share. $2,000,002
26-Jan-10 MARXE AUSTIN W & GREENHOUSE DAVID M
Beneficial Owner (10% or more) 388,350 Indirect Purchase at $5.15 per share. $2,000,002
21-Jan-10 VENROCK ASSOCIATES V LP
Beneficial Owner (10% or more) 388,350 Indirect Purchase at $5.15 per share. $2,000,002
For all practical purpose, these investors have essentially taken the company private and have only left enough float to maintain nasdaq's listing requirements. Of course the downside is that there is very little liquidity and a lot of volatility.
Nice progress in a rapidly expanding market. In the past 18 months, the company has been recapitalized, hired a new ceo and relocated their HQ to the US. They've gotten their MagLev LVAD into a clinical trial and have successfully implanted patients in Oklahoma, Utah and Virginia. The company has a market cap of around $35mm while their primary competitor HTWR has a market cap of over $800. As WHRT's current 160 patient BTT clinical trial progresses, I believe their valuation will be "discovered" in the market place.
Emerging ventricular assist devices for long-term cardiac support
Nature Reviews Cardiology (February 2010)
Rajan Krishnamani, David DeNofrio & Marvin A. Konstam
The evolution of mechanical cardiac support has been fueled by an increasing need to support patients with end-stage heart failure. More than 100,000 patients are estimated to have severe, refractory (AHA/ACC stage D) heart failure. The prognosis in this group of patients is dismal, with a 4-year mortality of more than 50%. Of patients admitted to hospital with acute heart failure, the 1-year mortality is 30–50%. The option of cardiac transplantation is limited by organ availability and, as wait times have increased, the need for mechanical cardiac support as a bridge-to-transplant has also increased.
Innovations in ventricular assist device (VAD) technology has provided an alternative therapeutic option for patients with advanced heart failure. Initiated as a mechanical option to 'bridge' critically ill patients awaiting transplantation, VADs are being increasingly deployed as 'destination' devices to provide long-term support. With technical advances resulting in improved mechanical reliability, reduced postoperative morbidity and greater likelihood of patient acceptance, there is interest in expanding the applicability for destination VAD treatment beyond the current indication of severely ill patients who are not candidates for transplant. This Review examines the newer, third-generation VADs for mechanical cardiac support.
WORLD HEART CORP
MARXE AUSTIN W & GREENHOUSE DAVID M DIRECTOR
340,200 shares @ $2.34 = $794,656.00
the volume has continued and the price continues to slowly rise even though Abiomed Inc is dumping their shares.
I'm thinking that major drop....LOL
I'm watching this real close. If we see another intraday drop in PPS to 11, I'm buyin a chuck.
As borat would say, wa wee woo wow! nice day today